Phase 2
N=17
A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
Myasthenia Gravis
Bottom Line
View on ClinicalTrials.gov: NCT03863080 ↗Enrolled (actual)
17
Serious AEs
6.3%
Results posted
Dec 2023
Primary outcome: Primary: Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 5; 4; 5; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- RVT-1401 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Immunovant Sciences GmbH
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-Blind Treatment Period: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
5; 4; 5; 0; 0; 1 | — |
| PRIMARY Open-Label Extension Period: Number of Participants Reporting AEs and SAEs |
10; 1 | — |
| PRIMARY Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Vital Signs |
0; 0; 0 | — |
| PRIMARY Open-label Extension Period: Number of Participants With Clinically Significant Changes in Vital Signs |
0; 0; 0 | — |
| PRIMARY Double-blind Treatment Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters |
0; 0; 0 | — |
| PRIMARY Open-label Extension Period: Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters |
0; 0; 0 | — |
| PRIMARY Double-Blind Treatment Period: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) |
0; 0; 0 | — |
| PRIMARY Open-label Extension Period: Number of Participants With Clinically Significant Changes in ECG |
0; 0; 0 | — |
| PRIMARY Double-blind Treatment Period: Percent Change From Baseline in Levels of Total Immunoglobulin G (IgG) |
-3.17; -59.49; -77.66 | <0.0001 sig |
| PRIMARY Double-blind Treatment Period: Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4 |
-3.3; -65.9; -76.3; -2.2; -54.7; -63.6 | <0.001 sig |
| PRIMARY Double-Blind Treatment Period: Percent Change From Baseline in Anti-acetylcholine Receptor Immunoglobulin G (Anti-AChR-IgG) at Week 7 |
15.92; -46.66; -85.28 | 0.0009 sig |
| SECONDARY Double-Blind Treatment Period: Area Under the Concentration-time Curve From Time 0 to 168 Hours (AUC0-168h) of RVT-1401 |
NA; NA | — |
| SECONDARY Open-label Extension Period: AUC0-168h of RVT-1401 |
NA; NA | — |
| SECONDARY Double-Blind Treatment Period: Maximum Concentration (Cmax) of RVT-1401 |
NA; NA | — |
| SECONDARY Open-label Extension Period: Cmax of RVT-1401 |
NA; NA | — |
| SECONDARY Double-Blind Treatment Period: Trough Concentrations (Ctrough) of RVT-1401 |
NA; NA | — |
| SECONDARY Open-label Extension Period: Ctrough of RVT-1401 |
NA; NA | — |
| SECONDARY Double-blind Treatment Period: Change From Baseline in the Quantitative Myasthenia Gravis Score (QMG) Score |
-3.3; -2.8; -1.7; -2.5; -4.6; -2.5 | — |
| SECONDARY Double-Blind Treatment Period: Percentage of Participants With an Improvement/ Response on the QMG Score From Baseline |
20.0; 40.0; 60.0 | — |
| SECONDARY Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Activities of Daily Living (MG-ADL) Score |
-1.7; -3.2; -0.7; -0.8; -3.8; -1.7 | — |
| SECONDARY Double-Blind Treatment Period: Percentage of Participants With an Improvement/ Response on the MG-ADL Score |
33.3; 60.0; 60.0 | — |
| SECONDARY Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Composite Score (MGC) Score |
-2.3; -7.0; -3.0; -1.3; -8.8; -2.3 | — |
| SECONDARY Double-Blind Treatment Period: Percentage of Participants With an Improvement on the MGC Score |
40.0; 60.0; 60.0 | — |
| SECONDARY Double-Blind Treatment Period: Change From Baseline in the Myasthenia Gravis Quality of Life 15 Revised Score (MG-QOL 15r) Score |
-3.5; -6.0; 1.6; -2.3; -6.6; 2.0 | — |
| SECONDARY Double-Blind Treatment Period: Number of Participants Reporting Confirmed Positive Anti-RVT-1401 Antibodies |
2; 1; 1 | — |
| SECONDARY Open-Label Extension Period: Number of Participants Reporting Confirmed Positive Anti-RVT-1401 Antibodies |
1; 0; 0 | — |
Summary
The purpose of the current study is to assess safety/tolerability and key pharmacodynamic (PD) effects that are considered to be associated with clinical benefit (reduction of total IgG and anti-AChR-IgG) in Myasthenia Gravis patients following treatment with RVT-1401 (also known as IMVT-1401) compared to placebo.
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 18 years of age.
- Myasthenia Gravis Foundation of America (MGFA) Class II-IVa and likely not in need of a respirator for the duration of the study as judged by the Investigator.
- QMG score ≥12 at Screening and Baseline.
Other, more specific inclusion criteria are defined in the protocol.
Exclusion Criteria
- Use of rituximab, belimumab, eculizumab or any monoclonal antibody for immunomodulation within 6 months prior to first dosing.
- Immunoglobulins given by SC, IV (IVIG), or intramuscular route, or plasmapheresis/plasma exchange (PE) within 4 weeks before Screening.
- Thymectomy performed < 12 months prior to screening.
- Total IgG level <6 g/L (at screening).
- Absolute neutrophil count <1500 cells/mm3(at screening).
Other, more specific exclusion criteria are defined in the protocol
Data sourced from ClinicalTrials.gov (NCT03863080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.